Healthy ParticipantsPhase 1NCT07641881
A Bioequivalence Study Between Two Casdatifan Tablet Strengths and Food Effect Study of Casdatifan in Healthy Adult Participants
A Phase 1 study testing Casdatifan in people with Healthy Participants, run by Arcus Biosciences, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to compare the single-dose pharmacokinetics (PK) of casdatifan 100 mg versus four 25 mg tablets under fasting conditions in healthy adult participants, and to evaluate the effect of food on the single-dose PK of casdatifan 100 mg administered as four 25 mg tablets in healthy adult… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Casdatifan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 29 May 2026to 7 Aug 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior to the first dosing based on participant self-reporting.
- BMI ≥ 18.0 and ≤ 32.0 kg/m2 and body weight ≥ 45 kg at the screening visit.
- Medically healthy with no clinically significant medical history, physical examination, clinical laboratory profiles, standard vital signs, and ECGs, as deemed by the PI or designee.
- Able to swallow multiple tablets.
- Has adequate peripheral venous access.
Who cannot join
- Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.
- History of any illness that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the participant by their participation in the study.
- History of asthma or chronic obstructive pulmonary disease (including childhood), clinically significant food allergies or anaphylaxis, as deemed by PI or designee.
- Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of asymptomatic gallstones).
- Seizure (excluding simple febrile seizure), epilepsy, severe head injury, multiple sclerosis, or other known neurological conditions which the PI or designee considers to be clinically significant.
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-Label, Randomized, Single-Dose, Three-Treatment, Three-Period, Six-Sequence Crossover Pharmacokinetic Study to Evaluate the Bioequivalence of Two Casdatifan (AB521) Tablet Strengths and Food Effect in Healthy Adult Participants
The purpose of this study is to compare the single-dose pharmacokinetics (PK) of casdatifan 100 mg versus four 25 mg tablets under fasting conditions in healthy adult participants, and to evaluate the effect of food on the single-dose PK of casdatifan 100 mg administered as four 25 mg tablets in healthy adult participants.
- Conditions
- Healthy Participants
- Being tested
- Casdatifan
- Keywords
- Casdatifan, AB521, HIF-2α, Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CasdatifanDrug
Also called AB521
Administered as specified in the treatment arm
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | Participants will receive 4 X 25 mg tablets of casdatifan. Receives: Drug: Casdatifan |
| Treatment B | Experimental | Participants will receive 1 X 100 mg tablets of casdatifan. Receives: Drug: Casdatifan |
| Treatment C | Experimental | Participants will receive 4 X 25 mg tablets of casdatifan under fed conditions. Receives: Drug: Casdatifan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed concentration for casdatifan
Measured: Up to 168 hours post each dose
Area under the concentration-time curve for casdatifan
Measured: Up to 168 hours post each dose
Secondary outcomes (8)
Time to reach Cmax (Tmax) for casdatifan
Measured: Up to 168 hours post each dose
Lag time (Tlag) for casdatifan
Measured: Up to 168 hours post each dose
Apparent first-order terminal elimination rate constant (Kel) for casdatifan
Measured: Up to 168 hours post each dose
Percent of AUC0-inf extrapolated for casdatifan
Measured: Up to 168 hours post each dose
Apparent first-order terminal elimination half-life (t½) for casdatifan
Measured: Up to 168 hours post each dose
Apparent total clearance after extravascular (oral) administration (CL/F) for casdatifan
Measured: Up to 168 hours post each dose
Apparent total clearance after extravascular (oral) administration (Vz/F) for casdatifan
Measured: Up to 168 hours post each dose
Number of participants experiencing Adverse Events (AEs)
Measured: Up to 43 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2026
- Study start29 May 2026
- Primary completion3 Jul 2026
- Study completion7 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arcus Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Taiho Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Arcus Biosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07641881
- Sponsor's protocol ID
- ARC-30
- Status last verified
- May 2026
- First submitted
- 8 Jun 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Arcus will provide access to individual de-identified participant data and related study documents (e.g., protocol, Statistical Analysis Plan \[SAP\], Clinical Study Report \[CSR\]) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. For more information, please visit our website.
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Randomized, Single-Dose, Three-Treatment, Three-Period, Six-Sequence Crossover Pharmacokinetic Study to Evaluate the Bioequivalence of Two Casdatifan (AB521) Tablet Strengths and Food Effect in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT07641881
- Acronym / sponsor ID
- ARC-30
- Conditions
- Healthy Participants
- Keywords
- Casdatifan, AB521, HIF-2α, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Arcus Biosciences, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Taiho Pharmaceutical Co., Ltd.
- Study start
- 29 May 2026 (actual)
- Primary completion
- 3 Jul 2026 (actual)
- Study completion
- 7 Aug 2026 (actual)
- First posted
- 11 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the single-dose pharmacokinetics (PK) of casdatifan 100 mg versus four 25 mg tablets under fasting conditions in healthy adult participants, and to evaluate the effect of food on the single-dose PK of casdatifan 100 mg administered as four 25 mg tablets in healthy adult participants.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Drug: CasdatifanParticipants will receive 4 X 25 mg tablets of casdatifan. |
| Treatment B | Experimental | Drug: CasdatifanParticipants will receive 1 X 100 mg tablets of casdatifan. |
| Treatment C | Experimental | Drug: CasdatifanParticipants will receive 4 X 25 mg tablets of casdatifan under fed conditions. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior to the first dosing based on participant self-reporting.
- BMI ≥ 18.0 and ≤ 32.0 kg/m2 and body weight ≥ 45 kg at the screening visit.
- Medically healthy with no clinically significant medical history, physical examination, clinical laboratory profiles, standard vital signs, and ECGs, as deemed by the PI or designee.
- Able to swallow multiple tablets.
- Has adequate peripheral venous access.
Key exclusion criteria (6 listed)
- Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.
- History of any illness that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the participant by their participation in the study.
- History of asthma or chronic obstructive pulmonary disease (including childhood), clinically significant food allergies or anaphylaxis, as deemed by PI or designee.
- Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of asymptomatic gallstones).
- Seizure (excluding simple febrile seizure), epilepsy, severe head injury, multiple sclerosis, or other known neurological conditions which the PI or designee considers to be clinically significant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CasdatifanAlso: AB521Administered as specified in the treatment arm | Drug | Treatment A, Treatment B, Treatment C |
Primary outcome
Maximum observed concentration for casdatifan
Time frame: Up to 168 hours post each dose
Area under the concentration-time curve for casdatifan
Time frame: Up to 168 hours post each dose
8 secondary outcomes
Time to reach Cmax (Tmax) for casdatifan
Time frame: Up to 168 hours post each dose
Lag time (Tlag) for casdatifan
Time frame: Up to 168 hours post each dose
Apparent first-order terminal elimination rate constant (Kel) for casdatifan
Time frame: Up to 168 hours post each dose
Percent of AUC0-inf extrapolated for casdatifan
Time frame: Up to 168 hours post each dose
Apparent first-order terminal elimination half-life (t½) for casdatifan
Time frame: Up to 168 hours post each dose
Apparent total clearance after extravascular (oral) administration (CL/F) for casdatifan
Time frame: Up to 168 hours post each dose
Apparent total clearance after extravascular (oral) administration (Vz/F) for casdatifan
Time frame: Up to 168 hours post each dose
Number of participants experiencing Adverse Events (AEs)
Time frame: Up to 43 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Individual participant dataSharing planned: Yes. Arcus will provide access to individual de-identified participant data and related study documents (e.g., protocol, Statistical Analysis Plan [SAP], Clinical Study Report [CSR]) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. For more information, please visit our website.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Arcus Biosciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Casdatifan in people with Healthy Participants, run by Arcus Biosciences, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum observed concentration for casdatifan (time frame: Up to 168 hours post each dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.